FDA Warns of Adverse Reactions to Steroid

The Food and Drug Administration is once again warning physicians and patients about adverse reactions to a steroid produced by a compounding pharmacy. The agency says the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy are investigating reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy in Newbern, Tennessee.

It is not clear how many patients have taken the drug. Steroid injections are often given to relieve back pain.

The FDA is recommending that health care providers not administer any products labeled as sterile from Main Street Family Pharmacy and to quarantine them until further notice.

The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. The patients are located in Illinois and North Carolina. At least one of the adverse events appears to involve fungus.

“An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication,” the FDA said in a statement.

Tennessee and federal health officials began inspections of the Main Street Family Pharmacy facility on May 22. The pharmacy has agreed to stop compounding sterile products and has begun a recall of all its sterile products, including the steroid.

Congress is considering legislation that would give the FDA greater authority over compounding pharmacies, which are largely under the regulation of individual states.